Utak Laboratories Inc

FDA Filings

This page includes the latest FDA filings for Utak Laboratories Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number2022375
FEI Number2022375
NameUTAK LABORATORIES, INC.
Owner & OperatorUTAK LABORATORIES, I
Contact Address25020 AVENUE TIBBITTS --
Valencia CA 91355 US
Official Correspondent
  • Kevin M Kopp
  • x-661-2943935-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address25020 AVENUE TIBBITTS
VALENCIA, CA 91355 US
Establishment TypeManufacture Medical Device

FDA Filings

Device
Company
DeviceDate
UTAK LABORATORIES, INC.
 TRAMADOL 400 NG/ML TRAM 400 U DEAW2025-10-06
UTAK LABORATORIES, INC.
 DRUGS OF ABUSE DA M QC RDL2025-09-12
UTAK LABORATORIES, INC.
 DRUGS OF ABUSE CAL DA M CAL RDL2025-09-12
UTAK LABORATORIES, INC.
 VOLATILES 150 MG/DL VOL 150 MMC 2025-09-03
UTAK LABORATORIES, INC.
 TESTOSTERONE PLUS LOW TESTO+ LOW S F BRL2025-09-02
UTAK LABORATORIES, INC.
 TESTOSTERONE PLUS HIGH TESTO+ HIGH S F BRL2025-09-02
UTAK LABORATORIES, INC.
 AED LEVEL 2 V3 AED 2 V3 S HCMC2025-09-02
UTAK LABORATORIES, INC.
 AED LEVEL 1 V3 AED 1 V3 S HCMC2025-09-02
UTAK LABORATORIES, INC.
 DRUGS OF ABUSE QC DAU QC F NSPCL2025-09-01
UTAK LABORATORIES, INC.
 PAIN PANEL URINE PAIN PAN U F ODX2025-08-25
UTAK LABORATORIES, INC.
 FENTANYL PLUS LEVEL 3 FENT+ 3 S F MAYO2025-08-25
UTAK LABORATORIES, INC.
 FENTANYL PLUS LEVEL 2 FENT+ 2 S F MAYO2025-08-25
UTAK LABORATORIES, INC.
 FENTANYL PLUS LEVEL 1 FENT+ 1 S F MAYO2025-08-25
UTAK LABORATORIES, INC.
 DRUGS OF ABUSE PANEL DAU PAN OF F ODX2025-08-25
UTAK LABORATORIES, INC.
 6TGR PLUS QC LEVEL 3 6TGR+ QC 3 UK2025-08-14
UTAK LABORATORIES, INC.
 6TGR PLUS QC LEVEL 2 6TGR+ QC 2 UK2025-08-14
UTAK LABORATORIES, INC.
 6TGR PLUS QC LEVEL 1 6TGR+ QC 1 UK2025-08-14
UTAK LABORATORIES, INC.
 VOLATILES VOL WB 2 PT2025-08-12
UTAK LABORATORIES, INC.
 DAU 2 V3 UCSD DAU LEVEL 2 V32025-08-07
UTAK LABORATORIES, INC.
 DAU LEVEL 1 V3 DAU 1 V3 UCSD2025-08-07
UTAK LABORATORIES, INC.
 URINE METALS LEVEL 3 U MET 3 V3 F UK2025-07-10
UTAK LABORATORIES, INC.
 URINE METALS LEVEL 2 U MET 2 V3 F UK2025-07-10
UTAK LABORATORIES, INC.
 URINE METALS LEVEL 1 V5 U MET 1 V5 F UK2025-07-10
UTAK LABORATORIES, INC.
 THC PLUS LEVEL 2 THC+ 2 WB 2PT F SDHL2025-06-19
UTAK LABORATORIES, INC.
 THC PLUS LEVEL 1 THC+ 1 WB 2PT F SDHL2025-06-19
UTAK LABORATORIES, INC.
 AMPHETAMINE PLUS LEVEL 2 AMPH+ 2 WB 2PT F V2 SDHL2025-06-19
UTAK LABORATORIES, INC.
 AMPHETAMINE PLUS LEVEL 1 AMPH+ 1 WB 2PT F V2 SDHL2025-06-19
UTAK LABORATORIES, INC.
 DRUGS OF ABUSE DAU V2 S SH2025-06-10
UTAK LABORATORIES, INC.
 MPA LEVEL 3 MPA 3 S V POTM2025-05-28
UTAK LABORATORIES, INC.
 MPA LEVEL 2 MPA 2 S V POTM2025-05-28
UTAK LABORATORIES, INC.
 CREATININE PLUS CREA+ A L DD2025-05-21
UTAK LABORATORIES, INC.
 COTININE PLUS 5 NG/ML COT+ 5 S WDL2025-05-21
UTAK LABORATORIES, INC.
 COTININE PLUS 25 NG/ML COT+ 25 S WDL2025-05-21
UTAK LABORATORIES, INC.
 AMPHETAMINE PLUS LEVEL 2 V4 AMPH+ 2 U V4 F WBH 2025-05-21
UTAK LABORATORIES, INC.
 GABAPENTIN LEVEL 3 GABA 3 V3 SMXU F PG2025-05-16
UTAK LABORATORIES, INC.
 GABAPENTIN LEVEL 2 GABA 2 V2 SMXU F PG2025-05-16
UTAK LABORATORIES, INC.
 GABAPENTIN LEVEL 1 GABA 1 V3 SMXU F PG2025-05-16
UTAK LABORATORIES, INC.
 ENDO LEVEL 3 STER 3 SMXS F SRL2025-04-23
UTAK LABORATORIES, INC.
 ENDO LEVEL 2 STER 2 SMXS F SRL2025-04-23
UTAK LABORATORIES, INC.
 ENDO LEVEL 1 STER 1 SMXS F SRL2025-04-23
UTAK LABORATORIES, INC.
 SMX CEREBRAL SPINAL FLUID 1ML SMX CSF F CP2025-04-10
UTAK LABORATORIES, INC.
 DRUGS OF ABUSE QC 3 DAU QC 3 V2 F BILH 2025-04-09
UTAK LABORATORIES, INC.
 DRUGS OF ABUSE QC 1 DAU QC 1 V2 F BILH2025-04-09
UTAK LABORATORIES, INC.
 DRUGS OF ABUSE QC LOW DA QC LOW U F UMHC2025-04-07
UTAK LABORATORIES, INC.
 DRUGS OF ABUSE QC HIGH DA QC HIGH U F UMHC2025-04-07
UTAK LABORATORIES, INC.
 CERTIFIED DRUG FREE URINE 88121-CDF(ASC)2025-04-01
UTAK LABORATORIES, INC.
 COMBINED OPIATES HIGH COMB OPIA HIGH U ADX2025-03-31
UTAK LABORATORIES, INC.
 MD LABS 23 LEVEL 2 V4 MD LABS 23 2 V4 OF2025-03-27
UTAK LABORATORIES, INC.
 MD LABS 23 LEVEL 1 V4 MD LABS 23 1 V4 OF 2025-03-27
UTAK LABORATORIES, INC.
 DRUGS OF ABUSE MID V2 DAU MID V2 F PG2025-03-27
UTAK LABORATORIES, INC.
 DRUGS OF ABUSE LOW V2 DAU LOW V2 F PG2025-03-27
UTAK LABORATORIES, INC.
 DRUGS OF ABUSE HIGH V2 DAU HIGH V2 F PG2025-03-27
UTAK LABORATORIES, INC.
 OPIOIDS QC OPI QC WB EBS2025-03-26
UTAK LABORATORIES, INC.
 DELTA-9-THC 8 NG/ML DELTA 9 OMEGA2025-03-26
UTAK LABORATORIES, INC.
 BROMIDE 1500 UG/ML BROM 1500 S CSU2025-03-21
UTAK LABORATORIES, INC.
 VORICONAZOLE PLUS LEVEL 3 VORI+ 3 V2 S CMCD2025-03-19
UTAK LABORATORIES, INC.
 VORICONAZOLE PLUS LEVEL 2 VORI+ 2 V2 S CMCD2025-03-19
UTAK LABORATORIES, INC.
 VORICONAZOLE PLUS LEVEL 1 VORI+ 1 V2 S CMCD2025-03-19
UTAK LABORATORIES, INC.
 DAU NEGATIVE DAU NEG U F BMC2025-03-18
UTAK LABORATORIES, INC.
 NICOTINE PLUS LEVEL 2 NIC+ 2 U F ADX2025-03-17
UTAK LABORATORIES, INC.
 NICOTINE PLUS LEVEL 1 NIC+ 1 U F ADX2025-03-17
UTAK LABORATORIES, INC.
 IODINE 20 UG/L IOD 20 V2 ADX2025-03-17
UTAK LABORATORIES, INC.
 IODINE 200 UG/L IOD 200 V2 ADX2025-03-17
UTAK LABORATORIES, INC.
 GLUCURONIDES HYDROLYSIS QC V2 GLUC QC V2 U CCHS2025-03-17
UTAK LABORATORIES, INC.
 DRUGS OF ABUSE 3 DA WB 3 V3 OCME2025-03-13
UTAK LABORATORIES, INC.
 ANTIPSYCHOTICS URINE PLUS V3 ANTIPSYCH+ V3 U F ODX2025-03-13
UTAK LABORATORIES, INC.
 BUSULFAN LEVEL 3 V2 BUS 3 V2 P F EBS UK2025-03-12
UTAK LABORATORIES, INC.
 BUSULFAN LEVEL 2 V2 BUS 2 V2 P F EBS UK2025-03-12
UTAK LABORATORIES, INC.
 BUSULFAN LEVEL 1 V2 BUS 1 V2 P F EBS UK2025-03-12
UTAK LABORATORIES, INC.
 TRACE ELEMENTS LEVEL 3 V2 TRACE 3 V2 S QD2025-03-10
UTAK LABORATORIES, INC.
 TRACE ELEMENTS LEVEL 2 V2 TRACE 2 V2 S QD2025-03-10
UTAK LABORATORIES, INC.
 TRACE ELEMENTS LEVEL 1 V2 TRACE 1 V2 S QD2025-03-10
UTAK LABORATORIES, INC.
 BUPRENORPHINE POS POS-236-2U 2025-03-03
UTAK LABORATORIES, INC.
 BENZOYLECGONINE POS POS-206-2U 2025-03-03
UTAK LABORATORIES, INC.
 THC POS POS-205-2U 2025-03-03
UTAK LABORATORIES, INC.
 VOLATILES VOL WB F DSH 2025-02-26
UTAK LABORATORIES, INC.
 THC 150 NG/ML THC 150 U ADX2025-02-26
UTAK LABORATORIES, INC.
 THC 1500 NG/ML THC 1500 U ADX2025-02-26
UTAK LABORATORIES, INC.
 DAU POSITIVE DAU POS U F BMC2025-02-20
UTAK LABORATORIES, INC.
 BUSULFAN LEVEL 1 BUS QC 1 F CMH2025-02-20
UTAK LABORATORIES, INC.
 METALS LEVEL 2 MET 2 V V2 S F UCSD2025-02-19
UTAK LABORATORIES, INC.
 METALS LEVEL 1 MET 1 V V2 S F UCSD2025-02-19
UTAK LABORATORIES, INC.
 TEPA PLUS LEVEL 3 V2 TEPA+ 3 V2 DP F MSKCC2025-02-18
UTAK LABORATORIES, INC.
 TEPA PLUS LEVEL 2 V2 TEPA+ 2 V2 DP F MSKCC2025-02-18
UTAK LABORATORIES, INC.
 DRUGS OF ABUSE DA WB 2PT V2 SDHL2025-02-17
UTAK LABORATORIES, INC.
 AMPHETAMINE PLUS 1000 NG/ML AMPH+ 1000 SDHL2025-02-17
UTAK LABORATORIES, INC.
 VOLATILES VOL U F OCMEO2025-02-14
UTAK LABORATORIES, INC.
 VOLATILES VOL SMX-VH F OCMEO 2025-02-14
UTAK LABORATORIES, INC.
 VOLATILES VOL S F OCMEO 2025-02-14
UTAK LABORATORIES, INC.
 VOLATILES VOL 2 WB F OCMEO2025-02-14
UTAK LABORATORIES, INC.
 VOLATILES VOL 1 WB F OCMEO2025-02-14
UTAK LABORATORIES, INC.
 ALPRAZOLAM PLUS LEVEL 3 ALP+ 3 V2 U F UK2025-02-13
UTAK LABORATORIES, INC.
 ALPRAZOLAM PLUS LEVEL 2 ALP+ 2 V2 U F UK2025-02-13
UTAK LABORATORIES, INC.
 ALPRAZOLAM PLUS LEVEL 1 ALP+ 1 V2 U F UK2025-02-13
UTAK LABORATORIES, INC.
 BUPRENORPHINE PLUS LEVEL 2 BUP+ 2 U ADX2025-02-11
UTAK LABORATORIES, INC.
 BUPRENORPHINE PLUS LEVEL 1 BUP+ 1 U ADX2025-02-11
UTAK LABORATORIES, INC.
 DRUGS OF ABUSE QC 3 DAU QC 3 F BILH2025-02-10
UTAK LABORATORIES, INC.
 DRUGS OF ABUSE QC 1 DAU QC 1 F BILH2025-02-10
UTAK LABORATORIES, INC.
 PM 25 V3 U F KP PM 25 V3 U F KP2025-02-03
UTAK LABORATORIES, INC.
 PAIN MANAGEMENT 100 NG/ML PM 100 V3 U F KP2025-02-03
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
TRICYLIC ANTIDEPRESSANTS Vi2016-10-19
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
TRICYLIC ANTIDEPRESSANTS Li Tx Control2016-10-19
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Whole Blood Lead Controls2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
UTAK Toxicology Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Trace Elements Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Clonazepam Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
UTAK STABBS Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Vancomycin Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Benzodiazepines Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Flurazepam Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Disopyramide Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Pentobarbital Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Caffeine Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Tricyclic Antidepressants Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Maprotiline Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Amoxapine Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
UTAK Toxicology Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Tricyclic Antidepressants Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Hypnotics + Salicylate Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Hypnotics + Acetaminophen Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Barbiturates Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Cardiacs II Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Cardiacs I Control2007-12-05
UTAK LABORATORIES, INC. [UTAK LABORATORIES, I]
Anticonvulsants Control2007-12-05
UTAK LABORATORIES, INC.
UTAK LABORATORIES TOXICOLOGY CONTROL1991-04-12
UTAK LABORATORIES, INC.
TRACE ELEMENTS SERUM TOXICOLOGY CONTROL1988-10-06
UTAK LABORATORIES, INC.
SERUM VANCOMYCIN TOXICOLOGY CONTROL1986-11-13
UTAK LABORATORIES, INC.
BENZODIAZEPINES TOXICOLOGY CONTROL1986-11-13
UTAK LABORATORIES, INC.
SERUM CLONAZEPAM TOXICOLOGY CONTROL1986-11-05
UTAK LABORATORIES, INC.
UTAK-STABBS TOXICOLOGY CONTROL1986-08-04
UTAK LABORATORIES, INC.
TRICYCLIC ANTIDEPRESSANTS1983-07-28
UTAK LABORATORIES, INC.
FLURAZEPAM TOXICOLOGY CONTROL1983-07-26
UTAK LABORATORIES, INC.
CAFFINE TOXICOLOGY CONTROL1983-07-26
UTAK LABORATORIES, INC.
MAPROTILINE1983-07-26
UTAK LABORATORIES, INC.
AMOXAPINE 8-HYDRO-XYAMOXAPINE1983-07-26
UTAK LABORATORIES, INC.
TRICYCLIC ANTIDEPRESSNATS VI1983-07-19
UTAK LABORATORIES, INC.
DISOPYRAMIDE N-DESALKYLDISOPYRAMIDE1983-07-06
UTAK LABORATORIES, INC.
PENTOBARBITAL TOXICOLOGY CONTROL1983-07-06
UTAK LABORATORIES, INC.
TOXICOLOGY CONTROL1981-02-04
UTAK LABORATORIES, INC.
TRICYCLIC ANTIDEPRESSANTS I TX CONTROL1980-05-02
UTAK LABORATORIES, INC.
TRICYCLIC ANTIDEPRESSANT II TX CONTROL1980-04-29
UTAK LABORATORIES, INC.
HYPNOTICS PLUS SALICYLATE TX CONTROL1980-04-29
UTAK LABORATORIES, INC.
HYPNOTICS PLUS ACETAMINOPHEN TX CONTROL1980-04-29
UTAK LABORATORIES, INC.
BARBITURATES TOXICOLOGY CONTROL1980-04-29
UTAK LABORATORIES, INC.
CARDIACS II TOXICOLOGY CONTROL1980-04-29
UTAK LABORATORIES, INC.
CARDIACS I TOXICOLOGY CONTROL1980-04-29
UTAK LABORATORIES, INC.
ANTICONVULSANTS TOXICOLOGY CONTROL1980-04-29

Related Finance Registrations
NCAGE Code1GED8UTAK LABORATORIES INC
NCAGE Code5Z914UTAK LABORATORIES INC
CAGE Code1GED8UTAK LABORATORIES INC
CAGE Code5Z914UTAK LABORATORIES INC
S.A.M. Registration1GED8 [92519016]UTAK LABORATORIES INC
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